Official title:
Scientific Foundations for Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index for Ethiopia

Clinical Trial Details
— Status: Not yet recruiting

Administrative data

NCT number

NCT03394963

Other study ID #

A4NH-FP1-CoA1

Secondary ID

Status

Not yet recruiting

Phase

First received

Last updated

Start date

November 1, 2019

Est. completion date

October 30, 2021

Study information

Verified date

February 2019

Source

Ethiopian Public Health Institute

Contact

Tesfaye Hailu Bekele, PhD student

Phone

00251944123108

Email

tesfayehailu.bekele[@]wur.nl

Is FDA regulated

No

Health authority

Study type

Observational

Clinical Trial Summary

Among several factors contributing to the occurrence of undernutrition, micronutrient
deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important
factors that need to be addressed to tackle the burden in low- and middle-income countries.
To maintain healthy eating in a population, it is crucial to develop and implement
country-specific food-based dietary guidelines as well as monitor the adherence of the
population with the guidelines. The aim of this study is to generate evidence that will help
the development and validation of food-based dietary guidelines and a healthy eating index
for Ethiopia. The method to develop Ethiopian food-based dietary guidelines is adapted from
the 2015 Dutch food-based dietary guidelines and the Dutch healthy diet index development and
validation process, and the 1998 FAO/WHO preparation and use of food-based dietary
guidelines. A multidisciplinary technical working will be established to develop FBDGs. The
working group will identify key messages for the guidelines that can address priority
diet-related public health problems in Ethiopia based on the evidence that will be generated
by the PhD student from Wageningen University and Research. The evidence generation will
begin by identifying top ten diet-related diseases that lead to high morbidity and mortality
in 2016. The nutrition situation (nutritional status, dietary pattern, and nutrient gaps)
analysis will be conducted to define the objectives of FBDGs. A systematic review will be
conducted by formulating research questions to address the objectives of the FBDGs. The FBDGs
will be translated for a specific population subgroup using linear mathematical programming
and validated for cultural appropriateness, acceptability, consumer understanding and
practicality of the messages. Focus group discussions and key informant interviews will be
conducted to validate the FBDGs. The most recent Ethiopian national food consumption survey
data collected in 2011 will be used to develop a healthy eating index (HEI). The selection of
a healthy eating component of HEI will be done based on the FBDGs. Validation of a healthy
eating index will be conducted by comparing the HEI score based on 24-hour recall with the
HEI score based on food frequency questionnaire for population characteristics and
association with micronutrient intake with or without adjusting for energy and anthropometric
measurement. Developing short food frequency questionnaire (FFQ) that can be scored with the
index for dietary counseling and public health practice as well as dietary gap assessment for
policy recommendation will be part of the study. Validation of FFQ will be conducted by
collecting primary data among women of reproductive age in 500 households in rural and urban
areas of Ethiopia. The data will be analyzed using the latest version of STATA, SPSS, and
NVIVO software. Correlations and other appropriate advanced statistical technique will be
applied as needed to answer the objectives of the study. Ethical approval will be received
from the medical ethical committee of Wageningen University and Research and scientific and
ethical review office of Ethiopian Public Health Institute. This Ph.D. research is supported
by the Food Systems for Healthier Diets flagship of the CGIAR- Agriculture for Nutrition and
Health Programme coordinated by International Food Policy Research Institute. Food and
Agriculture Organization (FAO) and Ethiopian Public Health Institute are collaborators of
this project to develop the FBDGs.

Description:

Triple burden of malnutrition (i.e. protein-energy malnutrition including micronutrient
deficiency and overnutrition) is a current global problem. In 2017, 155 out of 677 million
children in the world under the age of 5 years were stunted (height for age < -2 SD of the
WHO Child Growth Standards median), 52 million wasted (weight for height < -2 SD of the WHO
child growth standards median) and 41 million overweight (weight for height > 2 SD of the WHO
child growth standards median) with 93 million children at risk of overweight. Out of 5
billion adults worldwide, nearly 2 billion are overweight (BMI > 25 kg/m2) or obese (BMI > 30
kg/m2) and one in 12 has a type -2 diabetes mellitus. The mean prevalence of adult obesity in
the WHO data set was 7.5 ± 6.0% while adult overweight was much higher at 21.8 ± 10.2% and
adult underweight was 13.4 ± 7.0%. The median ratio of overweight to underweight among women
age 20 - 49 years was 5.8 in urban and 2.1 in rural areas of low- and middle-income countries
(LMICs). Even many poor countries, countries in which underweight persists as a significant
problem, had a fairly high prevalence of rural overweight. As compared to the overall
Sub-Saharan Africa (SSA), urban prevalence of adult obesity and overweight were higher (12.5
± 7.0% and 31.8 ± 12.8% respectively), child undernutrition was generally lower (30.4 ± 8.4%
for stunting < -2SD from median height for age,15.5 ± 7.0% for underweight < -2SD from median
weight for age and 12.0 ± 5.0% for wasting < -2SD from median weight for height) and adult
underweight (BMI < 18.5 kg/m2) was also 10.5%. In addition to this, two billion people living
in developing and developed countries are micronutrients deficient; they lack the vital
vitamins and minerals needed to grow properly and live healthily. Iron, iodine, vitamin A,
zinc, and folate separately or in combination are the priority micronutrient deficiencies for
populations in most countries of the world. Micronutrient deficiencies have consequences
throughout an individual's lifespan and are perpetuated across the generations. Thus,
maternal and child malnutrition in low- and middle-income countries encompasses
undernutrition and micronutrient deficiency, with a growing problem of overweight and
obesity. The problem of triple burden of malnutrition is especially increasing in low- and
middle-income countries mainly due to urbanization, fast economic growth, and changes in
dietary pattern and lifestyle.

Ethiopia has a fast growing economy over the past 10 years, and a changing food environment,
with declining shares of food expenditures and increased access to non-staples, processed
foods, and sugary beverages. Stunting among young children has reduced from 57% in 2000, to
40% in 2014. Nevertheless, levels of stunting are still among the highest in the world and
the contribution starts from underweight mothers whose birth outcome is a child with low
birth weight. According to 2016 demographic and health survey report, the prevalence of
stunting among under 5 children is 38%, wasting 9.9% and underweight 23.6%. The national
nutrition survey conducted by Ethiopian Public Health Institute (EPHI) in 2015 also indicated
that the prevalence of underweight (BMI<18.5 kg/m2) and overweight among women of
reproductive age are 20% and 13% respectively. Overweight had increased by 10% between 2009
and 2015 according to the national nutrition survey results and other studies. The national
micronutrient survey also showed that anemia, vitamin A, zinc, iodine, folate and vitamin B12
are public health problems among all population in Ethiopia. This indicates that, like other
LMICs, Ethiopia is suffering from the triple burden of malnutrition.

The unhealthy diet is one of the most important risk factors that need to be addressed to
tackle the triple burden of malnutrition in LMICs. The changes in the pattern of dietary risk
factors in low- and middle-income countries is characterized by increases in the consumption
of animal fat and protein, refined grains, and added sugar. In middle-income countries,
from1989 to 2011, the percentage of individuals with consumption frequency of fish 5 + per
week has decreased from 93% to 74%, that with consumption frequency of meat 5 + per week has
increased from 25% to 51%, consumption frequency of fruits 1 + per week has increased from
48% to 94%, consumption frequency of salty snacks 1 + per week has increase from 22% to 64%,
consumption frequency of sweet snacks has increased from 38% to 67%, and from 2004 to 2011,
consumption frequency of poultry has increased from 86% to 96%. On the other hand, in
Sub-Saharan African (SSA) countries, dietary micronutrient density index (average
micronutrient density of the food supply based on 14 micronutrients: calcium, copper, iron,
folate, magnesium, niacin, phosphorus, riboflavin, thiamin, vitamin A, vitamin B12, vitamin
B6, vitamin C, and zinc using the 2011 global population-weighted Recommended Dietary
Allowance [RDA]) has declined over the past 50 years. This indicates that there is a policy
gap in terms of improving dietary quality for better health, prevention of diet-related
diseases, and triple burden of malnutrition in LMICs setting. Promoting healthy eating in
low- and middle-income countries can reduce the social inequality among the poor and rich,
especially when it targets the disadvantaged population group. In general, healthy global
diet can reduce global mortality by 6 - 10%, and greenhouse emission by 29-70%, reduce
biodiversity loss and economic benefit up to 31 trillion US dollar and adoption of global
dietary guidelines would result in 5.1 million avoided deaths per year [95% confidence
interval (CI), 4.8-5.5 million] and 79 million years of life saved (CI, 75-83 million).

Besides this, lack of a healthy diet also contributes to the burden of diet-related diseases.
Intakes of a diet low in fruits and vegetables and high in sodium are the leading dietary
risks factors for non-communicable diseases (NCDs) burden in Ethiopia. Evidence from animal,
clinical and epidemiological studies also showed that specific dietary patterns are
associated with reduced risk of specific disease. Fruits and vegetables are associated with a
reduction of the incidence of an esophagus, lung, stomach, and colorectum cancer and coronary
heart diseases. In addition, by promoting a healthy diet, it is also possible to prevent
different forms of malnutrition and micronutrient deficiencies.

A healthy diet means eating a variety of foods that can give the nutrients needed to maintain
or improve health, feel good, and have adequate energy content. The nutrients include
protein, carbohydrates, fat, water, vitamins, and minerals. To maintain healthy eating in a
population, it is crucial to develop and implement country-specific food-based dietary
guidelines and to enable tracking the adherence of the population to the food-based dietary
guidelines.

Indications for dietary transitions are observed in several overall trends of Ethiopian
eating habits such as increased energy intake, declining but still a dominant share of
cereals in diets, and more purchased foods. Whether diets as a whole are changing towards
healthier or unhealthier patterns, and how this differs between and within regions and
population subgroups, is unclear. The increase in consumption of unhealthier components might
be faster than that of healthy components as in many (187 countries) other countries of the
world. In addition, Ethiopia's food production and supply are very vulnerable to climate
change and variability (droughts in 2015-2016), which leads to temporal high levels of severe
food insecurity and malnutrition which can easily affect the dietary pattern of the
population. A national food consumption study conducted by EPHI sheds light on some major
dietary gaps, including inadequate intake of vitamin A, calcium, folate and zinc. However,
the heterogeneity of dietary patterns and dietary nutrient gaps concerns among the large
diversity of consumers remain to be investigated and this heterogeneity currently limits
efficient targeting of food-based interventions. Filling this knowledge gap was identified
among the priorities of the nutrition research agenda of the country. Research could then
support the development of food-based dietary guidelines for the general population above the
age of 2 years.

Food-based dietary guidelines is a set of simple advisory statements that gives direction to
consumers on healthy eating patterns to promote better nutrition and well-being and to
address diet-related conditions. They provide advice on the type of food or food groups that
need attention to promote more optimal nutrition and health outcomes for a target population
in the country. The overall aim of food-based dietary guidelines is to promote overall
health, contribute to the management of specific diet-related diseases and prevention of the
risk factors, and to improve micronutrient deficiency and protein-energy malnutrition.
Food-based dietary guidelines can be used for dietary advice regarding national food supply
planning, better health status, reduced healthcare cost and improve work, growth and learning
capacity for different population groups.

Food-based dietary guidelines should be specific to a given country, should be appropriate in
terms of socio-demographic profile, nutritional status, health status, and dietary pattern to
provide a framework for a healthy diet based on current nutrition recommendations.
Country-specific food-based dietary guidelines are relevant due to foods that makeup diet are
more than just a collection of nutrients. The nutrients in food interact differently when
present as a food and the method of food preparation, processing, and cooking (i.e. food
culture) influence the nutritional values of food. Food-based dietary guidelines should
target the total diet, including all foods in daily meals and snacks, be based on food
commonly consumed and all type of foods. The list of food groups used in FBDGs should be
recognizable by consumers, permit the maximum flexibility in food choice to accommodate
different eating tradition in a country and the description of food serving size should be in
terms of commonly used household measures. Out of 58, only 7 African countries have FBDGs at
the moment. Ethiopia is one of those African countries which do not have food-based dietary
guidelines. In collaboration with FAO and other key local partners, Wageningen University and
Research (WUR) and EPHI planned to develop food-based dietary guidelines for Ethiopian
population above 2 years in the coming 4 years (until 2021).

The process for the development of the food-based dietary guidelines will have two major
parts; the first part is developing the guidelines and advising how to use it at individual
and HH level to improve dietary practice. To do this, establishing a national
multidisciplinary technical working group composed of multiple concerned sectors such as
ministry of health, ministry of agriculture and natural resources, ministry of livestock and
fisheries, ministry of education, universities, research institute and development partners
will be crucial to take into account different issues into consideration during the
development and translation of the key messages in the FBDGs. The technical committee will
agree on the key messages that have to be addressed on the FBDGs for the general population
above 2 years based on evidence generated by WUR and EPHI on the wealth of foods, nutrients
and health information, and other diet-related evidence and diet modeling. The general
guidelines will translate into every day healthy dietary choices for specific population
subgroups (women of reproductive age, school-age children, adolescent girls, adults and
elderly) based on their dietary reference values. Food guide will be designed using the most
commonly consumed foods in different regions of the country. In addition, dietary gap
assessment will be done to see how far the FBDGs implementation can be possible in Ethiopia
by comparing the current food supply with recommended healthy eating by the population. This
will lead additional recommendations for policymakers and technical experts to set
agriculture, trade and health target based on the demand formulated on Ethiopian food-based
dietary guidelines. During the second part of the process, a healthy eating index will be
developed which will be a measure of diet quality and relevant to evaluate the adherence to
FBDGs. It is also relevant to determine the risk of diet-related diseases such as arthritis,
diverticulitis, CVD, diabetes, common epithelial cancers, with colorectal cancer and
mortality risk in Ethiopia for any future research. Therefore, the aim of this study is
generating supportive evidence that will be useful for the development and validation of
food-based dietary guidelines and a healthy eating index to Ethiopia.

Recruitment information / eligibility

Status

Not yet recruiting

Enrollment

500

Est. completion date

October 30, 2021

Est. primary completion date

October 30, 2021

Accepts healthy volunteers

Accepts Healthy Volunteers

Gender

Female

Age group

2 Years to 65 Years

Eligibility

Inclusion Criteria:

- General population above 2 years of FBDGs development

- Women of reproductive age (15-49 years) for FBDGs validation

- Women of reproductive age (15-49 years) for HEI development and validation

Exclusion Criteria:

- population groups other than women of reproductive age for FBDGs validation, and HEI
development and validation.

Selection of the healthy eating components will be based on the food-based dietary guidelines developed for all Ethiopian above two years. Each component of a healthy eating index will have a minimum score of zero and maximum score between 5 to 20. The components will be scored in a way that a higher value indicates better adherence to the guidelines. The total healthy eating index score will not estimate an absolute energy intake rather it represents an intake per certain energy content. The total healthy eating index score (the sum of each components) ranges from 0 to 100, with higher scores indicating higher diet quality. The healthy eating index components will be categorized into adequacy, optimum, moderation, and ratio based on the healthier options provided in the food group of food-based dietary guidelines.

From June 2018 - October 2021

Primary

Calorie gap from different food groups

Estimating the dietary gap in different food groups mentioned in the food based dietary guidelines by comparing with world health organization nutrient reference intake for different population group.

From June 2018 - October 2021

Secondary

Top 10 diseases based on total number of disability-adjusted life-years (DALYs) among all age and sex in Ethiopia

Secondary data analysis from global burden of disease data

From June 2018 - October 2021

Secondary

Top 10 diseases based on total number of death among all age and sex in Ethiopia

Nutrition trend analysis using demographic and health survey, other national nutrition and health surveys and desktop review of published journals

From June 2018 - October 2021

Secondary

Height in meter

Nutritional status trend analysis such as stunting (height for age < -2 SD of the WHO Child Growth Standards median) analysis using demographic and health survey, other national nutrition and health surveys and desktop review of published journals

From June 2018 - October 2021

Secondary

Weight in kilogram

Nutritional status trend analysis such as wasting (weight for height < -2 SD of the WHO child growth standards median) and underweight (weight for height < -2 SD of the WHO child growth standards median) using demographic and health survey, other national nutrition and health surveys and desktop review of published journals

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